INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and IASO Biotherapeutics announced that their CAR-T cell therapy, IBI326, received Breakthrough Therapy Designation from China's NMPA. This designation, granted on Feb. 22, 2021, is based on results from an ongoing Phase 1/2 study for treating relapsed/refractory multiple myeloma. IBI326 is a fully-human CAR-T therapy targeting BCMA, showing rapid anti-myeloma activity and positive safety profiles. This designation may expedite its development and review in China, allowing earlier patient access.

Innovent Biologics has successfully dosed the first patient in a Phase III clinical trial (NCT04720716) for IBI310, an anti-CTLA-4 monoclonal antibody, in combination with TYVYT® (sintilimab injection) for advanced hepatocellular carcinoma (HCC). This multicenter trial aims to evaluate the efficacy and safety of this combination treatment, focusing on overall survival and response rate. With over 50 clinical centers involved, the study led by prominent professors is expected to provide valuable insights into new therapeutic options for HCC patients.

Innovent Biologics and Eli Lilly announced that China's National Medical Products Administration has approved TYVYT® (sintilimab injection) for treating nonsquamous non-small cell lung cancer (nsqNSCLC) in combination with pemetrexed and platinum chemotherapy. This approval follows a successful Phase 3 clinical trial (ORIENT-11) demonstrating significant improvements in progression-free survival (PFS) and overall survival (OS) for TYVYT® over placebo. This marks the second indication for TYVYT® since its initial approval for Hodgkin's lymphoma in December 2018.

Innovent Biologics has appointed Dr. Yong Jun Liu as the new president, enhancing its leadership in R&D and global operations. With over 30 years of experience, Dr. Liu has significant achievements in biotechnology, notably at AstraZeneca and Sanofi, where he led drug research initiatives. Innovent, established in 2011, has a robust pipeline of 23 assets and has approved four products in China, including TYVYT®, a PD-1 inhibitor. Dr. Liu's leadership is expected to strengthen Innovent's commitment to innovative drug development.

Innovent Biologics and Eli Lilly announced that HALPRYZA® (rituximab injection) has been approved by China's NMPA for treating non-Hodgkin's lymphoma and chronic lymphocytic leukemia. This marks Innovent's fourth monoclonal antibody approval, following TYVYT®, BYVASDA®, and SULINNO®. The drug will provide a more affordable treatment option for Chinese patients, enhancing healthcare access. With confirmed safety and efficacy in major clinical trials, HALPRYZA® aims to improve patient outcomes in a growing segment of hematological malignancies in China.

Innovent Biologics announced the expiration of the waiting period under the HSR Act, allowing its global collaboration with Eli Lilly for TYVYT® (sintilimab injection) to take effect. This milestone triggers a $200 million upfront payment. TYVYT® has received marketing approval in China for relapsed Hodgkin's lymphoma and is included in the NRDL. Innovent is actively engaged in over 20 clinical studies to assess TYVYT®'s efficacy in various cancers, bolstering its robust pipeline of oncology drugs.

Innovent Biologics, a leading biopharmaceutical company, will host a virtual R&D day on November 10, 2020, featuring two sessions: one in Mandarin from 8:00 AM to 12:00 PM and another in English from 9:00 PM to 1:00 AM (next day), both China/Singapore time. The event will cover the company's development, long-term vision, and an in-depth discussion on its R&D pipeline. Participants must register before November 8 to receive access details. Innovent is recognized for its innovative treatments, including three marketed products and a robust pipeline targeting major diseases.

Innovent Biologics announced that the ORIENT-32 Phase 3 trial of TYVYT® (sintilimab injection) combined with BYVASDA® (bevacizumab biosimilar injection) for treating advanced hepatocellular carcinoma met primary endpoints of progression-free survival (PFS) and overall survival (OS). This interim analysis showed significant improvements over sorafenib, with a safety profile consistent with prior studies. Innovent plans to discuss these results with the National Medical Products Administration in China to potentially advance treatment options for HCC patients.

Innovent Biologics and Eli Lilly presented biomarker results from the ORIENT-11 study at the ESMO Virtual Congress 2020. The trial evaluated TYVYT® (sintilimab injection) combined with ALIMTA® (pemetrexed) for first-line treatment of advanced nonsquamous non-small cell lung cancer (nsqNSCLC). Biomarker analysis indicated that the MHC-II pathway is linked to better progression-free survival (HR, 0.41; P=0.0041), suggesting its potential as a predictive marker. The Chinese NMPA has accepted a supplemental NDA for this combination therapy, indicating a significant step in cancer treatment advancements.